Cleared Traditional

K760428 - SUTURE RACK & NEEDLE COUNTER

K760428 is an FDA 510(k) clearance for SUTURE RACK & NEEDLE COUNTER, manufactured by Kleen Test Products. The device is a Class 1 General & Plastic Surgery device with product code FSM cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K760428 · Kleen Test Products · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1976
Decision
81d
Days
Class 1
Risk

K760428 is an FDA 510(k) clearance for the SUTURE RACK & NEEDLE COUNTER. Classified as Tray, Surgical, Instrument (product code FSM), Class I - General Controls.

Submitted by Kleen Test Products (Mchenry, US). The FDA issued a Cleared decision on November 2, 1976 after a review of 81 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4800 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Kleen Test Products devices

FDA 510(k) Submission Details - K760428

510(k) Number K760428 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 1976
Decision Date November 02, 1976
Days to Decision 81 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
34d faster than avg
Panel avg: 115d · This submission: 81d
Pathway characteristics
Predicate-based equivalence.

FSM Device Classification - Class 1, General Controls

Product Code FSM Tray, Surgical, Instrument
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4800
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - FSM Tray, Surgical, Instrument

All 37
Devices cleared under the same product code (FSM) and FDA review panel - the closest regulatory comparables to K760428.
WECK RACK (STERILIZING ACCESSORY TRAY)
K791743 · Edward Weck, Inc. · Sep 1979
INSTRUMENT TRAY
K772266 · Med Fusion Systems, Inc. · Jan 1978
ARMOR-KOT SURGICAL INSTRUMENTS
K771680 · Storz Instrument Co. · Nov 1977
INSTRUMENT RACK FOR DAWSON-YUHL INSTR.
K760579 · V. Mueller O.V. Baxter Healthcare Corp. · Nov 1976
INSTRUMENTS, GENERAL HAND & SURGERY
K760311 · Depuy, Inc. · Aug 1976